A Medical Device Daily

The New York Times said this week that it planned to appear in a Texas courtroom to request the release of documents that may show whether Guidant (Indianapolis) knew that its implantable defibrillator devices had a fatal flaw before selling them to patients without proper warning.

The newspaper filed a lawsuit in the 94th District Court in Nueces County, Texas, seeking disclosure of Guidant documents that it termed “potentially damaging“ for an upcoming Texas trial, the first involving Guidant's knowledge concerning defects in its defibrillator products, and given Class I recall status by the FDA.

Bob Hilliard, an attorney with Hilliard & Munoz (Corpus Christi, Texas), said that the documents sought “are not trade secrets, only evil secrets. They directly affect the public health and safety, and Guidant has wrongfully attempted to hide them from the public's view.“

Hilliard represents plaintiffs Louis Motal and Beatrice Hinojosa in the underlying lawsuit set for a February trial, as well as hundreds of others alleging injury by Guidant defibrillators.

“Sunshine is the best disinfectant, and now that the media are involved, hopefully the truth will come to light that these devices can kill people, and that Guidant doesn't seem to care,“ Hilliard said.

In other legalities:

Ferguson Medical Group (FMG; Sikeston, Missouri), a provider of local medical care and services, reported filing an antitrust action against Missouri Delta Medical Center (MDMC; Sikeston) alleging restraint of competition by MDMC for medical and diagnostic services. Other defendants are MDMC board member Robert Scott Matthews, and president and CEO Charles Ancell.

Jim Heath, MD, a managing partner at FMG, charged that MDMC “attempted but failed“ to prevent the company from bringing a freestanding MRI to the community. “Only after that failure did MDMC decide to replace the 20-year-old mobile unit it was having brought to town three times per week.“

The suit includes allegations of barriers to entry of new competition, lock-up of services through execution of exclusive contracting, interference with FMG's retention and/or recruitment of expert staff. The suit seeks treble damages and attorneys' fees for injury caused by MDMC and for money damages incurred by Ferguson.

A Miami investor has filed suit vs. clinical research provider SFBC International (Miami), charging inflation of its financials and improper recruiting of drug trial participants, initially revealed through investigations by Bloomberg News. The problems ranged from “payment schemes“ that discouraged trial participants from reporting adverse reactions to conflicts of interest and statements that SFBC's chairman was a medical doctor though she was not licensed to practice medicine in the U.S.

“From the day Bloomberg published its first article Nov. 2, 2005, until Dec. 15, 2005, [SFBC's] stock price fell more than 60%, from $41.49 to $15.78,“ according to the suit.

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